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NCT ID: NCT00445146 Completed - HIV Infections Clinical Trials

Safety of Ritonavir-Boosted Elvitegravir Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

Start date: February 2007
Phase: Phase 2
Study type: Interventional

This study is being initiated to provide continued access to ritonavir-boosted elvitegravir (EVG/r; GS-9137/r) for those participants currently benefiting from their participation in an ongoing EVG/r study. This study will also provide initial access to EVG/r for those participants who have completed a EVG/r study in which the participant was participating in a treatment arm that did not include EVG/r. While on study, participants will be monitored for safety using periodic assessments of concomitant medications, adverse events and laboratory tests. Participants will be seen once every 8 weeks for the first 48 weeks of the study. Upon completion of 48 weeks, study visits will occur once every 12 weeks until EVG becomes commercially available, or until Gilead elects to terminate the study.

NCT ID: NCT00443443 Completed - Clinical trials for Rheumatoid Arthritis

A Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)

SUNSTONE
Start date: January 2007
Phase: Phase 4
Study type: Observational

This is an observational study designed to follow patients with RA who have had an inadequate response to one or more anti-TNF therapies and who will receive Rituxan. Approximately 1000 patients in the United States with RA who have had an inadequate response to anti-TNF therapies and who will receive Rituxan therapy will be recruited. There is no protocol mandated treatment assignment in this study. Patients will be evaluated and treated according to their physician's standard practice and discretion.

NCT ID: NCT00442910 Completed - Healthy Clinical Trials

Safety and Acceptability of SPL7013 Gel (VivaGelâ„¢) in Sexually Active Women

Start date: July 2007
Phase: Phase 1
Study type: Interventional

There is an urgent need for HIV prevention methods that women can initiate and control themselves. Topical microbicides, substances that kill microbes, represent one such method. The purpose of this study is to assess the safety and to evaluate the acceptability of 3% w/w SPL7013 gel, a topical microbicide, when administered intravaginally for 14 consecutive days in healthy, sexually active HIV uninfected women.

NCT ID: NCT00441545 Completed - Clinical trials for Chronic Kidney Disease, Stage 5

Head to Head Study Against Sevelamer Hydrochloride

Start date: January 5, 2007
Phase: Phase 3
Study type: Interventional

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

NCT ID: NCT00440947 Completed - HIV Infection Clinical Trials

Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection

Start date: March 2007
Phase: Phase 3
Study type: Interventional

This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV +/r for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B*5701 negative subjects. All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks. The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study.

NCT ID: NCT00440557 Completed - Anemia Clinical Trials

An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease

Start date: September 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that once weekly and once every-2-weeks treatment with epoetin alfa, in patients with anemia associated with chronic kidney disease, is not less effective than the approved treatment with epoetin alfa that is given 3 times weekly with respect to changes in hemoglobin.

NCT ID: NCT00440193 Completed - Venous Thrombosis Clinical Trials

Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study

Start date: March 2007
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).

NCT ID: NCT00439777 Completed - Pulmonary Embolism Clinical Trials

Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study

Start date: March 2007
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).

NCT ID: NCT00437112 Completed - Clinical trials for Diabetes Mellitus, Type 2

Evaluate the Efficacy and Safety of Insulin Compared to Glargine in Patients With Type 2 Diabetes

Start date: February 2007
Phase: Phase 3
Study type: Interventional

A study to compare Human Inhalation Powder (also known as AIR® Inhaled Insulin) (AIR® is a registered trademark of Alkermes, Inc.)with insulin glargine injections in patients with Type 2 diabetes who are currently taking oral medications and have not previously taken insulin. Change in HbA1c levels will be reviewed to determine superiority or inferiority of the AIR Inhaled Insulin regimen.

NCT ID: NCT00435929 Completed - HIV Infections Clinical Trials

A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection.

Start date: September 2006
Phase: Phase 1
Study type: Interventional

This 2 arm study will assess the effect of moderate liver impairment on the pharmacokinetics of saquinavir and ritonavir at steady state following administration of saquinavir/ritonavir 1000mg/100mg po bid in HIV patients. Saquinavir/ritonavir will be administered concomitantly with 2 to 3 active nucleoside reverse transcriptase inhibitors. The study will compare a group of HIV patients without known liver disease and a group with moderate liver disease. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.